MELAFIND
STRATA SKIN SCIENCES, INC.MelaFind is a computer-vision system used by dermatologists that captures multispectral digital images of atypical pigmented skin lesions. It analyzes these images using AI algorithms to classify lesions based on their 3D morphological disorganization, assisting clinicians in deciding whether a biopsy is needed to detect melanoma or high-grade lesions earlier and more accurately.
Intended Use
Intended for use on clinically atypical cutaneous pigmented lesions with one or more characteristics of melanoma, excluding lesions with clinical diagnosis of melanoma or likely melanoma. It is used by trained dermatologists to obtain additional information for biopsy decisions.
Technology
MelaFind is a multi-spectral, non-invasive, automated computer-vision system that acquires 10 multispectral digital images per lesion (430-950 nm) using a hand-held imager. It uses a PC to calibrate, control image quality, segment lesions, extract features, and classify lesions as positive or negative based on morphological disorganization.
Performance
Clinical studies including a large prospective pivotal trial (Protocol 20061) enrolling 1383 patients with 1831 lesions showed MelaFind’s sensitivity for melanoma and high-grade lesions at 98.3% and specificity at 10.8%, outperforming dermatologists’ average specificity. A web-based reader study confirmed MelaFind’s higher sensitivity compared to dermatologists (97% vs 72%). Post-market study is required to further evaluate safety and effectiveness in practice.
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